How much rework can be added in same batch or other batches in tablets?
It depends upon the type of rework
1 Like
What is the purpose of adding reworked material in the same or next batch? Generally entire batch is reworked or reprocessed, if any processing error occurs during manufacturing.
Generally residues (tailings / left over quantities of finished product) from previous batches NMT 10% of total batch size should be added to the fresh batch. However, reworked material or residues (tailings / left over quantities) of previous batches must meet the finished product specifications (assay, imputities etc.) before adding to the fresh batch.
At any time rejected reworked / reprocessed material or rejected residues of previous batches must not be added to the fresh batch.
There should be internal SOP to govern this activity. It should define the maximum quantity of reworked material, residues of product to be added to the next batch, at what stage this is to be added to the fresh batch (dry mixing or granulation or lubrication stage is case of tablets) etc.
2 Likes
Recovery or rework addition in same or other batches.percentage and sop
You may add entire quantity of recovered or reworked material to the same batch and consider this batch as âReworked batchâ. It must meet the finshed product specification. I assume that you are referring formulation (such as tablets).
1 Like
please can u provide reference of limit NMT 10%
Rejected, recovered, reprocessed and reworked materials
14.29 The reworking or recovery of rejected products should be exceptional.
It is permitted only if the quality of the final product is not affected, if the specifications are met,
and if it is done in accordance with a defined and authorized procedure after evaluation of the risks involved. A record should be kept of the reworking or recovery. A reworked batch should be
given a new batch number.
14.30 The introduction of all or part of earlier batches, conforming to the required quality standards, into a batch of the same product at a defined stage of manufacture should be authorized beforehand. This recovery should be carried out in accordance with a defined procedure after evaluation of the risks involved, including any possible effect on shelf-life. The recovery should be recorded.
14.31 The need for additional testing of any finished product that has been reprocessed, reworked or into which a recovered product has been incorporated, should be considered by the QC department.
Refernce: WHO Guidelines TRS 986, 2014
WHO good manufacturing practices for pharmaceutical products: main principles, Annex 2
There is no specific guideline or reference to add specific % of recoveries / residues of previous batches in to next batches of the same products. However, it is an industrial practice that
generally residues (Tailings / left over quantities of finished product) from previous batches NMT 10% of total batch size should be added to the fresh batch.
in addition ,ensure ,the rework/reprocess process in validated.
Best to define what is rework and reprocess
Here are definitions of the terms as per WHO guidelines,
Recovery
The introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or the recovery of used materials for a
separate use.
Reprocessing
Subjecting all or part of a batch or lot of an in-process medicine, bulk process intermediate (final biological bulk intermediate) or bulk product of a single batch or lot to a previous step in the validated manufacturing process due to failure to meet predetermined specifications. Reprocessing procedures are foreseen as occasionally necessary for biological medicines and, in such cases, are validated and pre-approved as part of the marketing authorization.
Yes, Reprocessing should be validated.
However, since âReworkingâ is an unexpected occurrence and is not pre-approved as part of the
marketing authorization it may not be possible to validate.
Here are definitions of the terms as per WHO guidelines, (please ignor my eralier communication)
Recovery.
The introduction of all or part of previous batches (or of
redistilled solvents and similar products) of the required quality into another
batch at a defined stage of manufacture. It includes the removal of impurities
from waste to obtain a pure substance or the recovery of used materials for a
separate use.
Reprocessing.
Subjecting all or part of a batch or lot of an in-process
medicine, bulk process intermediate (final biological bulk intermediate) or bulk
product of a single batch or lot to a previous step in the validated manufacturing
process due to failure to meet predetermined specifications. Reprocessing
procedures are foreseen as occasionally necessary for biological medicines and, in
such cases, are validated and pre-approved as part of the marketing authorization.
Reworking.
Subjecting an in-process or bulk process intermediate (final
biological bulk intermediate) or final product of a single batch to an alternate
manufacturing process due to a failure to meet predetermined specifications.
Reworking is an unexpected occurrence and is not pre-approved as part of the
marketing authorization.
Yes, Reprocessing should be validated.
However, since âReworkingâ is an unexpected occurrence and is not pre-approved as part of the
marketing authorization it may not be possible to validate.
1 Like